甘露聚糖肽对非小细胞肺癌支持治疗的临床荟萃研究

Systematic review of mannatide injection in the treatment of non-small cell lung cancer

目的:系统评价甘露聚糖肽对非小细胞肺癌支持治疗的有效性及安全性。方法:电子检索Co-chrane图书馆、MEDLINE、EMBASE、CNKI、CBMDisc,纳入甘露聚糖肽治疗非小细胞肺癌的随机对照试验。制定严格的纳入排除标准纳入试验研究,评价文献质量,提取数据,并使用RevMan 5.0软件进行Meta分析。结果:纳入16项试验,共有912例患者,其中治疗组475例,对照组435例,结果显示甘露聚糖肽可显著提高化疗的总有效率[59.9%vs 42.3%,OR=2.18,95%CI(1.60,2.95),Z=5.00,P<0.01],亦显著提高肿瘤患者生存质量[67.3%vs 28.9%,OR=5.34,95%CI(2.17,13.16),Z=3.64,P<0.01]及T细胞免疫功能如CD3+[MD=8.36,95%CI(7.24,9.48);Z=14.67,P<0.01],CD4+[MD=13.57,95%CI(5.35,21.79),Z=3.63,P<0.01],CD4+/CD8+[MD=0.70,95%CI(0.56,0.85)Z=9.21,P<0.01]水平;同时能显著降低各种化疗引起的毒副反应如白细胞下降[38.9%vs 59.6%,OR=0.28,95%CI(0.12,0.63),Z=3.08,P<0.01]减少胃肠道不良反应[47.1%vs 73.8%;OR=0.26,95%CI(0.14,0.54),Z=3.73,P<0.01],等,然治疗过程中可引起轻微发热[43.1%vs 2.89%,OR=16.40,95%CI(3.42,78.68),Z=3.50,P<0.01]。结论:甘露聚糖肽可显著提高非小细胞肺癌常规放化疗的近期疗效,提高患者的免疫功能,减轻不良反应,改善生活质量。然上述结论需谨慎对待,需进一步开展更高质量的临床双盲研究予以证实。

Objective： To evaluate the efficacy and safety of mannatide injection in the treatment of non-small-cell lung cancer（NSCLC）.Methods： Literature was retrieved from Medline,EMBASE,Cochrane Library,CBM,VIP,and CNKI databases by computer and from relevant Chinese medical journals by hand.Trial selection,quality evaluation and information extraction were performed according to including and excluding criteria.Meta-analysis was conducted using RevMan 5.0 software.Results： A total of 16 reports and 912 patients were included in the meta-analysis,475 patients in treatment group and 435 in control group.The results showed that mannatide injection improved the total effect of chemotherapy [59.9% vs 42.3%,OR=2.18,95% CI（1.60,2.95）,Z=5.00,P0.01];quality of life [67.3% vs 28.9%,OR=2.18,95% CI（1.60,2.95）,Z=5.00,P0.01];and T cell immunologic functions,such as CD^＋3,CD^＋4,CD^＋4/CD^＋8.It also decreased toxicity of chemotherapy,such as decrease in WBC [38.9% vs 59.6%,OR=0.28,95% CI（0.12,0.63）,Z=3.08,P0.01] and gastrointestinal adverse reaction [47.1% vs 73.8%;OR=0.26,95% CI（0.14,0.54）,Z=3.73,P0.01].The main adverse reaction of mannatide injection was slight fever [43.1% vs 2.89%,OR=16.40,95% CI（3.42,78.68）,Z=3.50,P0.01].Conclusion： Mannatide injection can improve the total effect of chemotherapy for NSCLC,immunologic function and the quality of life.However,due to the limited quality of the included studies,further and multi-center and large-scale randomized double-blind control trials of mannatide injection are needed.